CLINTON, N.J., July 28 /PRNewswire/ -- Ikaria Holdings, Inc., a fully
integrated critical care biotherapeutics company, announced today that the
U.S. Food and Drug Administration (FDA) has granted orphan drug designation
for inhaled carbon monoxide for use in the reduction of the incidence and
severity of delayed graft function (DGF) in patients undergoing solid organ
transplantation.

Ralf Rosskamp, M.D., Executive Vice President of Research and
Development for Ikaria, commented, "The designation of orphan drug status
is a significant step that will greatly facilitate the development of
inhaled carbon monoxide as a potential treatment for DGF in solid organ
transplants. Pre-clinical data has demonstrated that the compound may
possess anti-inflammatory, cytoprotective and anti-apoptotic properties
that could potentially improve ischemic-reperfusion mediated malfunction in
transplanted organs and allow for an important advance in solid organ
transplantation. We look forward to advancing our research of inhaled
carbon monoxide as part of our overall goal of delivering new therapies for
the underserved critical care market."

Ikaria is currently conducting a single-blind, placebo controlled,
dose-escalating Phase 2 study of inhaled carbon monoxide in patients
receiving renal transplants. The primary endpoint of the study is to
evaluate the safety and tolerability of increasing carbon monoxide dose
levels when administered as an inhaled gas to kidney transplant patients
over the course of one hour in an acute hospital setting. The study was
initiated in August 2007 and is currently enrolling patients.

Delayed graft function following kidney transplantation represents an
unmet medical need with considerable health burdens. DGF occurs when the
kidney does not function sufficiently after transplantation, often
requiring dialysis to support the patient. The underlying cause of DGF is
ischemia-reperfusion injury, which occurs when blood flow is returned to
damaged tissue, leading to an inflammatory response that could result in
poor organ function. In the United States, approximately 28,000 patients
received a solid organ transplant in 2007.

Orphan drug designation provides an accelerated FDA review process, tax
advantages and a seven-year period of market exclusivity in the US upon
product approval.

About Ikaria Holdings, Inc.

Ikaria Holdings, Inc. is a fully integrated biotherapeutics company
focused on the development and commercialization of innovative
pharmaceutical and biological products and drug/device combinations for the
critically ill in the hospital and ICU setting. The company's product,
INOmax(R) (nitric oxide) for inhalation, is an FDA-approved drug for the
treatment of hypoxic respiratory failure in term and near-term newborns.
The drug also is approved by regulatory authorities and used in Canada,
Europe, Australia and Latin America. In addition to the ongoing clinical
development as well as the marketing and selling of its INOmax product,
Ikaria is engaged in a number of Phase 2 trials with Covox(R) (carbon
monoxide) for inhalation and Phase 1 trials with hydrogen sulfide (H2S) for
various critical care indications. Ikaria has a staff of approximately 400
people and is headquartered in Clinton, NJ, with research facilities in
Seattle, WA and Madison, WI and manufacturing in Port Allen, LA. For more
information on Ikaria, please visit http://www.ikaria.com.

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